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Objectionable Microorganisms: Considering the Risk

3 March 2015, Palo Alto, United States

Introduction

Why Should You Attend:Due to increased scrutiny by the FDA and other regulatory agencies, companies must now determine how to reduce the risk if they find objectionable microorganisms. This webinar will provide an expert's insight into reducing this risk.GMPs require that products be free of objectionable microorganisms and it is incumbent upon manufacturers to ensure their products meet these requirements. But just what is an objectionable microorganism? This webinar will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

Areas Covered in the Webinar:What is an objectionable microbe?Pathogens vs. objectionablesJust how objectionable is it?Consider the riskPerforming a risk assessmentExamples

Henry UrbachHenry Urbach is a founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving life sciences industries. He has over 20 years of life sciences experience having held positions of increased responsibility in training, QA, and QC microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing an environmental monitoring training program. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of life sciences training professionals.

ComplianceOnlineEnhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.Note: Use coupon code 232082 and get 10% off on registration.